This is a randomized, stratified, double-blind, placebo-controlled, parallel-group study in female subjects with HFs associated with menopause. This study will evaluate the efficacy of AMG 334 as measured by reduction from baseline in the frequency and severity of daily HFs at weeks 2, 4, 8, 12, and 16 after a single dose of AMG 334.

This is a randomized, stratified, double-blind, placebo-controlled, parallel-group study in female subjects with HFs associated with menopause. This study will evaluate the efficacy of AMG 334 as measured by reduction from baseline in the frequency and severity of daily HFs at weeks 2, 4, 8, 12, and 16 after a single dose of AMG 334.

Study Phase: 1b

Primary Objective:

To evaluate the frequency of moderate to severe daily HFs at week 4 after a single dose of AMG 334 in female subjects with HFs associated with menopause.

Secondary Objectives:

To evaluate changes in the severity of daily HFs at week 4 after a single dose of AMG 334 in female subjects with moderate to severe HFs associated with menopause.

To evaluate the safety, tolerability, and immunogenicity of AMG 334 in female subjects with HFs associated with menopause

To characterize the pharmacokinetic (PK) profile of AMG 334 after a single subcutaneous (SC) dose in female subjects with HFs associated with menopause

Hypotheses:

This study will test the hypothesis that the vasodilation associated with capsaicin-induced dermal blood flow (DBF) provides a good model for the vasodilation associated with HFs; therefore AMG 334 doses that cause DBF inhibition will be safe and well tolerated, and will be effective in the reduction of the frequency and/or severity of HFs.

Eligibility

Ages Eligible for Study:

45 Years to 65 Years (Adult)

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

female subjects with hot flashes associated with menopause between 45 and 65 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician.

Exclusion Criteria:

History or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890109